Author: Peter

Renown Health is paying $9.5 million to settle allegations of Medicare fraud after its former compliance director-turned whistleblower accused management of encouraging "systemic" overcharging — and sometimes double-billing — of hundreds of patients...U.S. Attorney Daniel Bogden announced the settlement agreement...between the Justice Department and...Renown Regional Medical Center, the largest hospital and health care network in northern Nevada with more than $1 billion in annual revenue...Cecilia Guardiola, a registered nurse and law school graduate, said in a federal whistleblower lawsuit filed in 2012 that she began to discover the "billing deficiencies" shortly after Renown hired her as its director of clinical documentation in June 2009...

Pfizer will build a biologics plant in China, where it will make biosimilars for the Chinese market but also for sale throughout the world. The New York drugmaker has turned to GE for construction of the facility, which has developed a modular construction process that will cut the cost and allow the plant to be operational in about 18 months, instead of three years...The $350 million facility, which it is building at the Hangzhou Economic Development Area in China, will be Pfizer’s third biologics production facility and its first in Asia. In addition to manufacturing, the facility will house Pfizer China’s Biosimilars and Biologics Quality, Technical Service, Logistics and Engineering divisions, and serve as a site for process development and clinical supplies. It will have about 150 employees when it is complete in 2018…The new center will be built using GE’s single-use technology…likened assembly to working with LEGO blocks...

A team of JAMA authors urged the FDA in 2014 to add "black box" warnings to dopamine agonists, linking the Parkinson's meds to pathological gambling, compulsive shopping and sexual obsessions...Public Citizen is upping the ante with a citizen petition to the agency, citing more than 80 studies supporting its claims...Public Citizen’s petition calls for stronger warnings on six FDA-approved medicines including GlaxoSmithKline’s Requip, Boehringer Ingelheim’s Mirapex and UCB’s Neupro. Used to treat Parkinson’s disease and restless leg syndrome, the medicines can cause uncontrollable urges that in turn lead patients to divorce, financial ruin and suicide attempts…

Consumers like the convenience and accessibility of urgent care clinics. But hospitals may have found another model that better meets the needs of patients: the "micro-hospital."...While the state of Colorado prefers to call them "community hospitals," these licensed facilities offer emergency medical care, inpatient care, surgery, laboratory and radiology services...SCL Health...plans to open four locations in neighborhood settings with it's partner Emerus. The facilities are priced higher than urgent care centers, but less than a full-service hospital, and can treat a wider range of conditions because they have inpatient beds..."Micro-hospitals like this are more suited for large urban and suburban metro areas,"..."This model would probably be too large and complex for a rural market. It definitely is a trend...to create more accessible, cost-effective access points and alternative delivery models."...

...two Chinese companies　with ties to Western drugmakers have been called on the mat to account for problems in their manufacturing. The FDA has issued warning letters to plants operated by Shanghai Desano Chemical Pharmaceutical and Chongqing Lummy Pharmaceutical, slamming them both for manipulating testing and turning in falsified batch test results on APIs...

• Shanghai Desano Chemical Pharmaceutical - FDA...criticized the facility for conducting "unofficial" tests of drug batches that it kept out of its official record...also disturbed by finding many electronic logs of production deviations in a folder titled "GMP Anomalies" that had never been investigated…
• Chongqing Lummy Pharmaceutical...FDA...warning letter slams the drugmaker for widespread and serious data manipulation of batch analyses...In one egregious case, the FDA...an analyst set the gas chromatography personal computer clock back to make it appear as if testing had been done...7 months earlier. The analyst then performed 5 injections to produce falsified results for long-term stability for a finished API lot, deleted four and reported only the results of the final injection as passing in the quality-control...

Researchers at ITMO University in St. Petersburg, Russia, have developed a magnetically controlled treatment designed to dissolve blood clots. The method looks to be a promising solution to some of the complications associated with enzyme-based thrombolytic drugs...To make the targeted drug, the scientists combined the mineral magnetite with the enzyme urokinase, commonly used as a thrombolytic agent. The nanosized particles can then be localized around a blood clot using an external magnetic field...The combination demonstrated up to 4,000 times more efficiency than the enzyme-based drugs alone...Now we are using a sledgehammer to crack a nut… In order to change the situation, we decided to develop a method of targeted drug delivery that would allow us to considerably reduce the dosage and ensure that the whole therapeutic effect is focused on the clot...

Drug Enforcement Administration released the 2016 National Heroin Threat Assessment Summary – Updated...The report outlines the expanding public health crisis afflicting America due to the use and abuse of heroin and other opioid drugs. Some key facts:

• The number of people reporting current heroin use nearly tripled between 2007 (161,000) and 2014 (435,000).
• Deaths due to synthetic opioids, such as fentanyl and its analogues, increased 79 percent from 2013 to 2014.
• Deaths involving heroin more than tripled between 2010 (3,036) and 2014 (10,574) – a rate faster than other illicit drugs.

Mike Glaicar, Business Development: Pharmacy Times...(PTNN) This weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings and more.

Megamergers could fall out of favor over the next year...small- to mid-sized deals up to $25 billion? Expect those aplenty given “the need many larger companies have to try and boost their growth prospects.”

Medivation’s prized prostate cancer pill Xtandi

Incyte, a $14.7 billion market-cap company that boasts myelofibrosis med Jakafi.

Epacadostat is entering Phase III combo studies...is being studied in a range of other tumor types

Alexion, a $27 billion company whose Soliris--the priciest med in the world--leads a portfolio of three approved rare-disease drugs.

BioMarin, the perennial subject of takeover buzz with 5 marketed meds and a host of pipeline prospects.

Gilead Sciences won regulatory approval...to sell a new hepatitis C combination drug, which can combat all six strains of the disease, and priced it below its older treatments...Epclusa, combines the older Sovaldi (sofosbuvir)medication with the newer velpatasvir, and costs $74,760 for a 12-week course of treatment, although that’s before any rebates are offered to payers. This is less than the list prices for both Sovaldi and Harvoni, another Gilead hepatitis C treatment...Gilead has argued its treatments are more affordable than paying for liver transplants, cancer, and hospitalizations. To what extent the newest drug will cause payers concern is unclear. Epclusa will cost roughly half of the most commonly used treatment regimen for patients with Genotype 3 of the disease...(which)...is...the most difficult to treat and one of the reasons Epclusa was granted priority review by the FDA...One consumer advocate charged the pricing for the new drug was out of line...Gilead still doesn’t get it — their pricing is outrageous. Once again, Gilead has shown that it is more concerned with protecting its profits rather than making its drugs available to all Americans...